1.0 OBJECTIVE

To validate the electronic calculators used in calculations of analytical results in quality control laboratories against manual calculations based upon mathematical principals.

2.0 SCOPE

The scope of this protocol is to verify the validation of calculators for all the mathematical calculations of analytical results as per requirement.

3.0 RESPONSIBILITY

The validation group comprising of a representative from Quality Control department shall be responsible for the preparation and execution of this protocol. The representative from Quality Assurance department shall be responsible for the review and final authorization of this protocol.
The specific individual responsibilities are mentioned below:
3.1 Sr. Officer / Executive – Quality Control
3.1.1 Preparation of the Protocol
3.1.2 Execution of the protocol
3.2 Executive – Quality Assurance / Manager – Quality Control
3.2.1 Checking and Review of the Protocol for correctness and completeness.
3.2.2 Verification of the design aspects of protocol with respect to the analytical method Validation.
3.2.3 Required data shall be made available, wherever applicable.
3.2.4 Checking and Approval of the Method Qualification Report.

5.0 General Information and Operation

It is to provide a documented evidence for above mentioned and other In house and pharmacopoeial tests calculations that the data calculated from calculator is correct against manual calculations based upon mathematical principals.

5.1 Operation and Procedure

5.1.1 The validation of electronic calculators operation includes the verification of correct key punched against displayed digits and mathematical operators on the screen of an individual calculator.
5.1.2 Acceptance Criteria:
The validation of electronic calculators shall be qualified if it meets all the acceptance criteria mentioned in below:
a. The punched key digit and operator should match the digit and operator displayed on the screen.
b. Operate the calculator using a pre-determined mathematical formula and simultaneously calculate it manually and compare the results. The result obtained from calculator should correspond to manual calculations.

Test Data Sheet-1, Verification of Keys of calculator

Used Key

Observation Displayed in Calculator screen

Observation

Observed By

Reviewed By

0

0

OK/Not OK

1

1

OK/Not OK

2

2

OK/Not OK

3

3

OK/Not OK

4

4

OK/Not OK

5

5

OK/Not OK

6

6

OK/Not OK

7

7

OK/Not OK

8

8

OK/Not OK

9

9

OK/Not OK

=

=

OK/Not OK

+

+

OK/Not OK

-

-

OK/Not OK

X

X

OK/Not OK

÷

÷

OK/Not OK

Manual Calculation:
Do manual calculation for above

Test Data Sheet-2, Functional Verification of calculator

Function

Operator

Test

Observation from Calculator

Result obtained by Mathematical Calculation

Observed By

Reviewed By

Addition

+

5 + 10

Subtraction

-

10 – 5

Multiplication

X

5 x 10

Division

÷

10 ÷ 5

Average

+ and ÷

Average of 2, 3, 4 and 5

Percentage

X and ÷

9.82 out of 10

Manual Calculation:
Do manual calculation for above

6.0 Conclusion
On the basis of the observation and results obtained in the respective test data sheet-1 and test data sheet -2, it is concluded that electronic calculator which is being used in Quality Control Laboratory is validated as per this protocol.